Neurolac TW

Basic Information

• Brand Name: Neurolac TW
• Primary DI: 08717703990447
• Version / Model: 3.0 mm
• Catalog Number: NG02-030/03
• Company Name: Polyganics Innovations B.V.
• Labeler DUNS: 489946080
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-17
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 890b12d3-6d9f-4bce-af6a-d44ebf1208b5

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXI	Cuff, Nerve	Neurology	882.5275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44814	Nerve guide, bioabsorbable, synthetic	An implantable tubular device intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. The device is typically used during hand surgery and/or nerve reconstruction. It is made of a synthetic substance or material that can be chemically degraded and typically absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, or a nerve wrap.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08717703990447	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K112267	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	3	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 4 Degrees Celsius